Lenahan v. University of Chicago

March 31, 2004

[5] KAREN LENAHAN, AS SPECIAL ADMINISTRATOR OF THE ESTATE OF SHAWN LENAHAN, DECEASED, PLAINTIFF-APPELLANT,v.THE UNIVERSITY OF CHICAGO, AN ILLINOIS NOT FOR PROFIT CORPORATION; THE UNIVERSITY OF CHICAGO HOSPITALS, AN ILLINOIS CORPORATION; DAVID LIEBOWITZ; XCYTE THERAPIES, INC., A DELAWARE CORPORATION; ARCH DEVELOPMENT CORPORATION, AN ILLINOIS NOT FOR PROFIT CORPORATION; AND STEPHANIE F. WILLIAMS, DEFENDANTS-APPELLEES.

[11] The decedent suffered from non-Hodgkin's lymphoma, a type of cancer. He was first treated at Central DuPage Hospital in August 1998, where his type of cancer was misdiagnosed and as a result he received improper chemotherapy that allowed his disease to progress unchecked. After he was rediagnosed by Indiana University Hospital in October 1998, he began a different chemotherapy/radiation treatment plan, which was later discontinued and changed to high-dose salvage chemotherapy.

[12] In November 1998, the decedent went to the University of Chicago Hospitals, where he was treated by Doctor Ginna Laport. Doctor Laport recommended that he be treated with a high-dose chemotherapy/stem-cell transplant regimen. Doctor LaPort also recommended that the decedent participate in a phase I clinical trial (referred to as Protocol 8558) at the University of Chicago Hospitals being run by University of Chicago doctors. Protocol 8558 involved a treatment plan whereby some of the patient's T-cells would be collected before the start of the chemotherapy/stem cell regimen; an experimental lab technique would be used to select particular T-cells and stimulate them to produce an immune reaction to cancer cells; the colony of such selected and stimulated cells would be grown and expanded in the lab, outside the patient's body; and the expanded T-cells would be reinfused into the patient's body at the end of the high-dose chemotherapy/stem cell procedure, in the hope that they would fight any remaining cancer cells and help restore the patient's immune system.

[13] The decedent enrolled in Protocol 8558. During the course of the treatment, he died.

[14] In counts XIII and XIV, subparagraphs a through p of paragraph 26, plaintiff alleged institutional negligence against the University of Chicago (University) and University of Chicago Hospital, Inc. (Hospital), directly and independently, based on each institution's failure to provide and obtain from the decedent an adequate informed consent to participate in Protocol 8558.

[15] In counts XIII and XIV, subparagraph q of paragraph 26, plaintiff alleged institutional negligence against the University and Hospital based on their failure to provide competent personnel to observe the treatment given and to remove the decedent at the first sign of adverse symptoms.

[16] In counts XVI and XVII, plaintiff alleged medical negligence against Doctor Liebowitz, based on his involvement as the doctor directing research in Protocol 8558.

[17] In counts XVIII and XIX, plaintiff alleged that Doctor Liebowitz, Xcyte Therapies, Inc. (a privately held biotech company), Arch Development Corporation (the University's business development company), the University and the Hospital conspired to conduct Protocol 8558, knowing that human subjects would be recruited using a consent form that concealed their expectation that 95% of the participants would die.

[20] Dismissal of a cause of action pursuant to section 2-615 is appropriate only when it clearly appears that no set of facts could ever be proved under the pleadings that would entitle the plaintiff to recover. Mt. Zion State Bank & Trust v. Consolidated Communications, Inc., 169 Ill. 2d 110, 115 (1995). On review of an order granting a section 2-615 motion, all well-pleaded facts and all reasonable inferences from them are taken as true. Mt. Zion Bank, 169 Ill. 2d at 115. Whether a complaint states a valid cause of action is a question of law, and our review of a dismissal pursuant to a section 2-615 motion is de novo. Majumdar v. Lurie, 274 Ill. App. 3d 267, 268 (1995).

[21] I. THE DISMISSAL OF COUNTS XIII AND XIV, SUBPARAGRAPHS a THROUGH p OF PARAGRAPH 26

[22] First, plaintiff argues that by answering counts XIII and XIV of the original complaint after their first motion to dismiss was denied, defendants waived their right to bring a subsequent section 2-615 motion to dismiss counts XIII and XIV of the fifth amended complaint. Plaintiff cites Adcock v. Brakegate, Ltd., 164 Ill. 2d 54, 60 (1994), which held that where a trial court denies a defendant's motion to dismiss a complaint, and that defendant elects to file an answer to the complaint, the defendant waives any defect in the pleading. Plaintiff's argument is unavailing, as the allegations pled in counts XIII and XIV of the fifth amended complaint differ from the allegations in counts XIII and XIV of the original complaint. Defendants did not waive their right to bring a section 2-615 motion to dismiss the allegations raised for the first time in counts XIII and XIV of the fifth amended complaint.

[23] On the merits, plaintiff argues that the trial court erred by dismissing counts XIII and XIV, subparagraphs a through p of paragraph 26, which alleged institutional negligence against the University and Hospital, directly and independently, based on each institution's failure to provide and obtain from the decedent an adequate informed consent to participate in Protocol 8558. *fn1 Specifically, plaintiff alleged that during the decedent's enrollment in Protocol 8558, the University and the Hospital were signatories to a policy stating that they each bear an independent institutional responsibility to obtain informed consent from all human subjects in the clinical trial, and that such informed consents must comply with applicable Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) rules and regulations as set forth in Titles 21 and 45 of the Code of Federal Regulations (CFR) (21 C.F.R. §50.25 (2003); 45 C.F.R. §46.116 (2003)). Pursuant to this policy, the University and Hospital formed an Institutional Review Board to ensure that the consent forms complied with the FDA and DHHS regulations.

[24] Plaintiff pleaded that the University and Hospital deviated from its policy and from the FDA and DHHS regulations by negligently failing to disclose in the decedent's consent form all the risks and alternatives to treatment. Plaintiff pleaded that the decedent's injuries and death were caused by his participation in Protocol 8558, and that the decedent would not have participated in Protocol 8558 if the University and Hospital had provided him with an adequate consent form detailing all the risks and alternatives to treatment.

[25]&nbsp;&nbsp; The elements of a negligence cause of action are a duty owed by the defendant to the plaintiff, a breach of that duty, and an injury proximately caused by the breach. Jones v. Chicago HMO Ltd. of Illinois, 191 Ill. 2d 278, 294 (2000). Here, plaintiff has adequately pleaded that the University and Hospital owed the decedent the duty to provide him with a consent form complying with FDA and DHHS regulations, that ...

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